The Federal Court of Appeal has upheld the decision of Justice O'Reilly of the Federal Court invalidating Eli Lilly's selection patent for the compound olanzapine (ZYPREXA): Eli Lilly Canada Inc v Novopharm Limited, 2012 FCA 232, aff'g 2011 FC 1288. The appeal marks the second time the Court of Appeal has considered the validity of the ZYPREXA patent. Previously, the Court of Appeal had reversed a finding of invalidity by Justice O'Reilly and returned the matter to him for further consideration, including on the issue of utility: Eli Lilly Canada Inc v Novopharm Limited, 2010 FCA 197, rev'g 2009 FC 1018.
As reported in the December 2011 issue of Rx IP Update, on November 10, 2011, the Trial Judge had found that the utility promised by the patent had not been demonstrated and could not have been soundly predicted. Justice O'Reilly held that the promise is "[o]lanzapine is substantially better ('marked superiority') in the clinical treatment of schizophrenia (and related conditions) than other known antipsychotics, with a better side-effects profile, and a high level of activity at low doses."
Justice O'Reilly found that by the Canadian filing date, and as disclosed in the patent, Lilly had concluded studies, including a six-month study in dogs, received the results of healthy volunteer studies, as well as preliminary data from clinical trials. The patent explicitly compared olanzapine favourably to two other compounds of the prior genus patent regarding a number of side-effect parameters. Despite this data, Justice O'Reilly held that utility had not been demonstrated, finding the evidence available to Lilly was not sufficient to demonstrate that olanzapine met the promise that "it would provide markedly superior clinical treatment of schizophrenia with a better side-effects profile than other known antipsychotics" when administered over a long term.
As for sound prediction, Justice O'Reilly accepted the Court of Appeal's finding that a sufficient factual basis existed for a sound prediction; however, he found that "one could not reasonably infer from the available evidence that olanzapine would treat schizophrenia patients in the clinic in a markedly superior way" and "with fewer side-effects, than other known antipsychotic drugs." Therefore, he held that the inventors could not draw a prima facie reasonable inference to the promise of the selection patent.
On September 10, 2012, Lilly's appeal was dismissed from the bench, without substantive reasons. The ruling signals that the courts intend to continue to apply a strict standard for patentable utility, measured against the "promise" gleaned from the disclosure. As noted above, the patent was a compound patent in which data from human clinical trials were disclosed in the patent. In contrast, both the U.S. and U.K. courts declined to invalidate the corresponding patents and utility was not in issue: Dr Reddy's Laboratories (UK) Ltd v Eli Lilly and Company Ltd,  EWCA Civ 1362 and Eli Lilly and Co v Zenith Goldline Pharmaceuticals Inc, (2006) 471 F.3d 1369.
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